EP2421456B1 - Système pour cerclage osseux minimalement invasif utilisant un élément de sertissage et un câble - Google Patents

Système pour cerclage osseux minimalement invasif utilisant un élément de sertissage et un câble Download PDF

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Publication number
EP2421456B1
EP2421456B1 EP10716442.8A EP10716442A EP2421456B1 EP 2421456 B1 EP2421456 B1 EP 2421456B1 EP 10716442 A EP10716442 A EP 10716442A EP 2421456 B1 EP2421456 B1 EP 2421456B1
Authority
EP
European Patent Office
Prior art keywords
lumen
crimp
sleeve
cerclage
cable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP10716442.8A
Other languages
German (de)
English (en)
Other versions
EP2421456A1 (fr
Inventor
Alberto A. Fernandez Dell'oca
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synthes GmbH
Original Assignee
Synthes GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synthes GmbH filed Critical Synthes GmbH
Publication of EP2421456A1 publication Critical patent/EP2421456A1/fr
Application granted granted Critical
Publication of EP2421456B1 publication Critical patent/EP2421456B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7022—Tethers, i.e. longitudinal elements capable of transmitting tension only, e.g. straps, sutures or cables
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8861—Apparatus for manipulating flexible wires or straps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/842—Flexible wires, bands or straps

Definitions

  • the invention relates generally to surgical apparatus for treating bones and more particularly to an apparatus for bone fixation using cable for a bone cerclage technique.
  • Bones are often treated using cerclage techniques in which a wire or other cable is wrapped around a portion of bone to facilitate fixation or repair thereof.
  • Cerclage procedures generally require that a wire or cable looped around the bone be secured tightly with current devices and methods requiring, adjacent the target portion of bone, at least one incision large enough to permit the insertion of bone cerclage tools for inserting and securing the cable around the bone.
  • these techniques generally require an incision large enough to permit the insertion and manipulation of a cable crimping tool capable of applying the force necessary to crush or deform a crimp over the cable.
  • Such systems and methods are of limited utility in minimally invasive procedures.
  • Other known orthopedic cerclage systems incorporate a cable and a screw extending perpendicular to a free end of the cable and tightened thereover to secure the cable in a desired configuration. However, these systems are also difficult to employ in minimally invasive procedures.
  • the present invention is directed to an apparatus and system for securing a cerclage member about a bone.
  • the apparatus according to the present invention comprises a crimp including a first lumen extending therethrough from a first lumen proximal opening to a first lumen distal opening and being configured to slidably receive a cerclage member therein.
  • a proximal portion of the first lumen comprises a first recess configured to receive an enlarged proximal end of the cerclage member.
  • the crimp further comprises a second lumen extending parallel to the first lumen from a second lumen proximal opening to a second lumen distal opening.
  • a distal portion of the second lumen comprises a second recess configured to slidably receive a sleeve provided over a distal end of a cerclage member.
  • a first wall of the crimp adjacent the second lumen distal opening is angled with respect to a second wall of the crimp adjacent the first lumen distal opening to permit pivoting of the sleeve thereagainst as the sleeve is drawn thereagainst through the tensioning of the cerclage member drawn therethrough.
  • the present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.
  • the present invention relates generally to devices for the stabilization and fixation of fractured bones and bone fragments via a minimally invasive cerclage system.
  • the present invention relates to devices for securing a cerclage wire or cable in a desired position around a target portion of bone.
  • Embodiments of the present invention may also be employed with any of a plurality of treatment procedures involving cerclage.
  • proximal and distal refer to a direction along the cerclage cable with a first end of the cable being identified as the proximal end and a second end of the cable being identified as distal.
  • Components of an exemplary crimp according to the present invention will then be described in relation to the direction in which the cable passes therethrough.
  • an opening to a lumen into which a distal end of the cable is inserted and against which a proximal end of the cable is held will be described as the proximal opening of the lumen.
  • the opposite end of the lumen from which the distal end of the cable exits will be described as the distal opening of the lumen and the other elements of the crimp will be similarly identified.
  • a crimping device 100 comprises a crimp 102 for receiving a cable 10 to be looped around a target portion of bone (not shown).
  • the crimp 102 defines first and second lumens 104, 106 extending therethrough from a first substantially planar face 108 to a second face 110 substantially parallel to one another.
  • the second face 110 comprises a first beveled surface 112 adjacent an opening to the second lumen 106 angled relative to a longitudinal axis of the second lumen 106 so that, when the crimp 102 is in a desired position, the beveled surface faces a bone over which the crimp 102 is positioned.
  • a second surface 114 of the second face 110 adjacent an opening to the first lumen 104 extends substantially perpendicular to the longitudinal axes of the first and second lumens 104, 106.
  • the angle of the second surface 114 relative to the longitudinal axes of the lumens 104, 106 may be varied as desired without departing from the scope of the invention.
  • the second surface 114 extends substantially perpendicular to third and fourth lateral faces 118, 120 which extend between the first and second faces 108, 110.
  • the first beveled portion 112 extends relative to the second surface 114 at an angle selected to permit pivoting and deformation of the cable 10 thereagainst when the cable 10 is to be crimped in a desired configuration, as will be described in greater detail later on.
  • the diameters of the first and second lumens 104, 106 are substantially equal to one another and are selected to permit slidable insertion of the cable 10 therethrough with minimal lateral movement of the cable 10 therewithin.
  • the diameter of the first and second lumens 104, 106 is substantially equal to an outer diameter of the cable 10 plus a small clearance to permit the cable 10 to slide smoothly therethrough. As shown in the partial cross-sectional views of Figs.
  • a proximal portion of the first lumen 104 includes a first increased diameter recess 115 configured to receive therein a cable stop 12 at a proximal end of the cable 10.
  • the first recess 115 extends into the first lumen 104 by a length substantially equivalent to a length of the cable stop 12 along the cable 10 and is preferably sized and shaped to match a profile of the cable stop 12.
  • the first recess 115 and the cable stop 12 are substantially cylindrical.
  • first recess 115 and cable stop 12 may be formed with any shape so long as the profile of the cable stop 12 is greater than a diameter of the distal portion of the first lumen 104 to prevent the cable stop 12 and the proximal end of the cable 10 from being drawn distally through the first lumen 104.
  • a distal end (not shown) of the cable 10 is inserted into a proximal end of the first lumen 104 and drawn distally therethrough until the cable stop 12 is positioned within the first recess 115 so that engagement of the cable stop 12 with a distal end of the first recess 115 prevents the proximal end of the cable 10 from being drawn through the crimp 102.
  • the beveled surface 112 is angled so that, as the sleeve 128 is drawn thereagainst through the tensioning of the cable 10 drawn therethrough, the sleeve 128 is pulled against the angled surface tilting it toward the bone over which the crimp 102 is positioned.
  • the sleeve 128 is formed of a material which may be plastically deformed (e.g., by being crushed) to retain a deformed shape which will lock a portion of the cable extending therewithin relative to the sleeve 128.
  • the sleeve 128 may be formed of Stainless Steel, Titanium (Ti), Titanium Alloys, Cobalt Chromium (CoCr), plastics or bioresorbable materials (e.g., Magnesium).
  • Ti Titanium
  • CoCr Cobalt Chromium
  • plastics or bioresorbable materials (e.g., Magnesium).
  • a desired tension is applied to the cable 10 as described below causing the sleeve 128 to tilt toward the bone over which the crimp 102 is placed.
  • a crimping tool such as the tool 200 of Figs. 16-17 is then inserted through the minimally invasive incision and the sleeve 128 is crushed over the cable 10 to lock the cable 10 in a desired position and at a desired tension around a target portion of bone as will be described in more detail below.
  • the third and fourth lateral faces 118, 120 extending between the first and second faces 108, 110 are substantially parallel to one another.
  • Fifth and sixth lateral faces 124, 126 extend between and are substantially perpendicular to the third and fourth faces 118, 120.
  • the third face 118 further comprises a second beveled portion 122 extending over the fifth face 124 to connect to the fourth face 120, as shown in Figs. 4 - 9 .
  • the second beveled portion 122 reduced the outer profile of the crimp 102 while also reducing tissue irritation caused by the crimp 102.
  • the cable 10 is initially positioned within the first lumen 104 with the cable stop 12 seated within the first recess 114.
  • target portions of bone (not shown) are moved relative to one another into a desired corrective position (e.g., by reducing a fracture) prior to insertion of the cable 10 into the body.
  • the crimp 102 and the cable 10 are inserted through a minimally invasive incision formed adjacent the target portions and the crimp 102 is positioned over one of the target portions.
  • the minimally invasive incision may be 2.54-5.08 cm. in length although smaller incisions are also envisioned without deviating from the scope of the present invention.
  • the crimp 102 is approximately 10 mm wide and 10 mm. long, dimensions thereof being selected to ensure a minimal outer profile when seated over the bone.
  • the cable 10 is then wound around the target portions of bone to hold the target portions of bone together as desired and the distal end of the cable 10 is inserted into a channel 130 in the sleeve 128 and slid proximally over the cable 10 into the second recess 116.
  • a crimping tool 200 may then be positioned over the free end of the cable 10.
  • the crimping tool 200 comprises an outer substantially cylindrical member 202 having a first handle 204 at a proximal end thereof and an inner substantially cylindrical member 206 having a second handle 208 at a proximal end thereof.
  • the inner cylindrical member 206 is configured and dimensioned to be positioned within the outer cylindrical member 202 and remain rotatable relative thereto via rotation of the first and second handles 204, 208.
  • a distal end 210 of the outer cylindrical member 202 comprises a first end wall 212 extending substantially perpendicularly to a longitudinal axis of the outer cylindrical member 202 and extending into a channel 214 extending through the outer cylindrical member 202 by a predetermined distance.
  • the first end wall 212 may extend over approximately one half of a distal end of the channel 214 although this dimension may be changed as required to conform to the requirements of a procedure being performed and the dimensions of the cable 10.
  • a first sharpened edge 216 is provided on the first end wall 212 to permit crimping and subsequent clipping of the sleeve 128 and cable 10, as will be described in greater detail hereinafter.
  • the inner member 206 comprises a lumen 218 extending therethrough configured to receive the cable 10 while preventing the sleeve 128 from being inserted therethrough.
  • a second end wall 220 formed on a distal end of the inner member 206 is located proximally of the first end wall 212 and formed substantially similarly to the first end wall 212.
  • the second end wall 220 further comprises a second sharpened edge 222 with a leading edge thereof facing the first sharpened edge 216.
  • the first and second handles 204, 208 are configured such that, when in alignment with one another (i.e., positioned over one another), the first and second sharpened edges 216, 222 are located adjacent one another with a distal opening 219 of the lumen 218 sealed by the first end wall 212.
  • the first and second handles 204, 208 are rotated out of alignment from one another by a predetermined angle sufficient to expose the distal end 219 of the lumen 218.
  • the free end of the cable 10 may then be inserted through the lumen 218 so that the sleeve 128 is positioned between the crimping tool 200 and the bone (not shown).
  • the cable 10 is then tensioned to a desired level as would be understood by those skilled in the art so that a desired force is applied to the bone.
  • the first and second handles 204, 208 are brought into alignment by, for example, rotating the second handle 208 in the direction A toward the position of the first handle 204.
  • This movement causes the second sharpened edge 222 to move in the direction A, so that the sleeve 128 is compressed by the first and second end walls 212, 220.
  • This compression causes a deformation of the sleeve 128 against the first beveled portion 112 and angles the sleeve 128 toward the target portions of bone. Specifically, this force simultaneously drives the sleeve 128 against the crimp 102 and against the bone so that an outer profile of the sleeve 128 relative to the bone is minimized.
  • compression of the sleeve 128 against the bone reduces an outer profile of the crimping device 100, thereby reducing potential soft tissue irritation by the sleeve 128.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Neurology (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Surgical Instruments (AREA)

Claims (12)

  1. Appareil de fixation d'un organe de cerclage (10) autour d'un os, comprenant :
    un sertissage (102) incluant une première lumière (104) s'étendant longitudinalement à travers celui-ci à partir d'une ouverture proximale de la première lumière jusqu'à une ouverture distale de la première lumière, la première lumière étant dimensionnée et formée pour recevoir de façon coulissante l'organe de cerclage à l'intérieur, une partie proximale de la première lumière comprenant un premier évidement (115) dimensionné et formé pour recevoir une extrémité proximale agrandie de l'organe de cerclage, le sertissage comprenant en outre une deuxième lumière (106) s'étendant sensiblement parallèlement à la première lumière à partir d'une ouverture proximale de la deuxième lumière jusqu'à une ouverture distale de la deuxième lumière, une partie distale de la deuxième lumière comprenant un deuxième évidement (116) dimensionné et formé pour recevoir de façon coulissante un manchon (128) agencé sur une extrémité distale d'un organe de cerclage,
    caractérisé en ce qu'une première paroi (112) du sertissage adjacente à l'ouverture distale de la deuxième lumière est inclinée par rapport une deuxième paroi (110) de sertissage adjacente à l'ouverture distale de la première lumière pour permettre un pivotement du manchon contre celle-ci lorsque le manchon est tiré contre celle-ci via la mise en tension de l'organe de cerclage tiré à travers celle-ci.
  2. Appareil selon la revendication 1, dans lequel le premier évidement a un diamètre accru par rapport à la première lumière.
  3. Appareil selon la revendication 1, dans lequel le deuxième évidement a un diamètre accru par rapport à la deuxième lumière.
  4. Appareil selon la revendication 1, dans lequel la première lumière et la deuxième lumière s'étendent parallèlement l'une à l'autre.
  5. Appareil selon la revendication 1, dans lequel les première et deuxième lumières sont sensiblement cylindriques.
  6. Système de fixation d'un organe de cerclage autour d'un os, comprenant :
    un appareil selon la revendication 1 ;
    un organe de cerclage incluant un organe de butée à diamètre accru (12) au niveau d'une extrémité proximale, l'organe de butée étant configuré pour une insertion dans le premier évidement mais pour l'empêcher d'entrer dans la première lumière ; et
    un manchon (128) configuré pour se déplacer par coulissement sur l'organe de cerclage, le manchon étant configuré pour être déformable lorsqu'il est au moins partiellement positionné dans le deuxième évidement.
  7. Système selon la revendication 6, dans lequel le manchon comprend une partie mécaniquement fragilisée définissant un emplacement de déformation souhaité sur celui-ci.
  8. Système selon la revendication 6, comprenant en outre un deuxième biseau (122) situé sur l'organe de sertissage, configuré pour minimiser un profil externe de l'organe de sertissage.
  9. Système selon la revendication 6, dans lequel le premier évidement a un diamètre accru par rapport à la première lumière et le deuxième évidement a un diamètre accru par rapport à la deuxième lumière.
  10. Système selon la revendication 6, comprenant en outre un outil de sertissage (200) configuré pour déformer le manchon sur l'organe de cerclage, l'outil de sertissage comprenant un premier organe tubulaire ayant une première lumière s'étendant à travers celui-ci et une première poignée au niveau d'une extrémité proximale de celui-ci et un deuxième organe tubulaire logé avec faculté de rotation au sein du premier organe tubulaire, le deuxième organe tubulaire comprenant une deuxième lumière s'étendant à travers celui-ci et configuré pour recevoir l'organe de cerclage, le deuxième organe tubulaire comprenant une deuxième poignée située au niveau d'une extrémité proximale de celui-ci, dans lequel une rotation de la première poignée en alignement avec la deuxième poignée amène les première et deuxième faces de sertissage situées sur des extrémités distales respectives des premier et deuxième organes tubulaires à appliquer une force de sertissage de compression sur le manchon et l'organe de cerclage.
  11. Système selon la revendication 10, dans lequel les première et deuxième faces de sertissage s'étendent sensiblement perpendiculairement à des axes longitudinaux des premier et deuxième organes tubulaires.
  12. Système selon la revendication 11, dans lequel les première et deuxième faces de sertissage comprennent des bords affûtés.
EP10716442.8A 2009-04-25 2010-04-23 Système pour cerclage osseux minimalement invasif utilisant un élément de sertissage et un câble Not-in-force EP2421456B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17272009P 2009-04-25 2009-04-25
PCT/US2010/032245 WO2010124211A1 (fr) 2009-04-25 2010-04-23 Système et procédé pour cerclage osseux minimalement invasif utilisant un élément de sertissage et un câble

Publications (2)

Publication Number Publication Date
EP2421456A1 EP2421456A1 (fr) 2012-02-29
EP2421456B1 true EP2421456B1 (fr) 2015-09-09

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EP10716442.8A Not-in-force EP2421456B1 (fr) 2009-04-25 2010-04-23 Système pour cerclage osseux minimalement invasif utilisant un élément de sertissage et un câble

Country Status (7)

Country Link
US (1) US20100274249A1 (fr)
EP (1) EP2421456B1 (fr)
JP (1) JP5612668B2 (fr)
KR (1) KR101685176B1 (fr)
CN (2) CN102413780B (fr)
CA (1) CA2758279C (fr)
WO (1) WO2010124211A1 (fr)

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Publication number Publication date
JP2012524635A (ja) 2012-10-18
WO2010124211A1 (fr) 2010-10-28
US20100274249A1 (en) 2010-10-28
CA2758279C (fr) 2017-07-18
CN104127230B (zh) 2017-04-12
KR20120014115A (ko) 2012-02-16
EP2421456A1 (fr) 2012-02-29
CA2758279A1 (fr) 2010-10-28
CN102413780A (zh) 2012-04-11
CN104127230A (zh) 2014-11-05
CN102413780B (zh) 2014-08-20
JP5612668B2 (ja) 2014-10-22
KR101685176B1 (ko) 2016-12-09

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